Home / 510(k) Clearances / K250109

510(k) K250109

TYBR Collagen Gel by Tybr Health — Product Code OWY

K250109 is an FDA 510(k) premarket notification submitted by Tybr Health for the device "TYBR Collagen Gel". The FDA issued a decision of Substantially Equivalent on June 6, 2025. The device falls under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
January 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

Other clearances for product code OWY

  • K251690 — Arthrex SpeedFLEX™ Implant (September 30, 2025)
  • K252647 — Tapestry Biointegrative Implant (September 19, 2025)
  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K242631 — REGENETEN™ Bioinductive Implant (November 26, 2024)
  • K222501 — Regeneten Bioinductive Implant (May 11, 2023)
  • K220867 — Tapestry Biointegrative Implant (May 23, 2022)
  • K212306 — Tapestry Biointegrative Implant (November 2, 2021)
  • K201572 — TAPESTRY Biointegrative Implant (October 19, 2020)
  • K151083 — BioBridge Collagen Matrix (January 8, 2016)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)

FDA data resources